AbelZeta Gains FDA IND Clearance for Bispecific CAR-T C-CAR039 in LBCL
Shots:
- AbelZeta has received FDA clearance for the IND application for C-CAR039 (prizloncabtagene autoleucel), an anti-CD20/CD19 bispecific CAR-T therapy, for r/r large B-cell lymphoma (LBCL)
- AbelZeta regained global development, regulatory, manufacturing, & commercialization rights to C-CAR039 in Jul 2026 & is working with the FDA to finalize clinical protocols for 3L or later LBCL pts previously treated with CAR-T therapies & 2L CAR-T-naïve pts
- The program is supported by long-term data from 48 Chinese pts with r/r B-cell non-Hodgkin lymphoma, showing a 91.5% ORR & 85.1% CR rate, with an mPFS of 60.1mos. at 53.9mos. of follow-up
Ref: PRnewswire | Image: AbelZeta | Press Release
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